Clinical Research Scientist
The Clinical Research Scientist (CRS) supports the Medical Monitor and Clinical Development function in the design, conduct, analysis, and writeup of clinical trials. The CRS also supports the Clinical Operations function in the conduct and documentation of clinical trials.
- Participate in regular and ad-hoc data reviews; prepare and present data summaries
- Support the medical monitor with the development of documents such as clinical protocols, clinical study reports, abstract and manuscripts, presentations, and investigator brochures.
- Conduct searches of the scientific and medical literature and summarize data from relevant publications
- Contribute to trial-related documents such as the statistical analysis plan, the data management plan, the medical monitoring plan
- Assist the medical monitor with protocol deviation review
- Assist Clinical Operations with developing the operational strategies for clinical research studies and development programs (e.g. PI selection, CRO selection, budgets)
- As agreed with the medical monitor, manage trial-related committees such as Safety Review Committees
- Assist with protocol training
- Assist with responding to regulatory questions and site IRB or EC questions
- Assist in preparation of regulatory submissions (e.g. INDs, IND Annual Reports, Safety Updates, BLAs, MAAs).
- Effectively collaborate with cross-functional study teams and project core teams
- Ensure that clinical documents are accurate, high-quality, and compliant with relevant regulations.
- Minimum Bachelor's degree in a related field. Master's degree preferred.
- Minimum of 1 year work experience in a clinical research environment
- Ability to understand technical, scientific and medical information with minimal explanation
- Good organizational and planning skills
- Ability to work effectively in a team/matrix environment
- Working knowledge of Good Clinical Practice
- Ability to problem-solve
- Competency with the Microsoft Office Suite (Word, Excel, Powerpoint)
- Excellent writing skills
- Ability to travel up to 20%